Genesis Ii

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: GENESIS II FDA UDI
Generic Name: Uncoated knee tibia prosthesis, polyethylene FDA UDI
Device Name: GII CONSTRAINED INSERT TRIAL W/JOURNEY LOCK SZ 7-8 15MM FDA UDI
Model / Reference: 71934402 FDA UDI
Description: GII CONSTRAINED INSERT TRIAL W/JOURNEY LOCK SZ 7-8 15MM FDA UDI

Identifiers

Catalog Number: 71934402 FDA UDI
Primary DI / UDI-DI: 00885556084939 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Uncoated knee tibia prosthesis, polyethylene FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Uncoated knee tibia prosthesis, polyethylene

Genesis Ii by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Gemini SL — WALDEMAR LINK GmbH & Co. KG · Class II
Triathlon — Howmedica Osteonics Corp. · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
Freedom — MAXX ORTHOPEDICS INC. · Class II
GMK Primary Total Knee System — Medacta International · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI aca0d496-7d0e-48e7-ab49-11441cdea2e3 35 fields · synced Jun 8, 2026